FDA to Review Atezolizumab for the Treatment of Non-Small Cell Lung Cancer

Roche has recently been granted priority review by the FDA, who has also accepted their supplemental biologics license application for atezolizumab. Atezolizumab is intended for the treatment of non-small cell lung cancer (NSCLC) without certain mutations, such as EGFR or ALK. These decisions have come after positive results were produced from the IMpower110 study. Roche hopes that the success of this medication continues, as a large amount of lung cancer cases are NSCLC. If atezolizumab performs well, it could provide a viable treatment option for many.

About Non-Small Cell Lung Cancer

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, coming in three different forms: adenocarcinomas, squamous cell carcinomas, and large cell carcinomas. The majority of cases are caused by smoking cigarettes, but exposure to certain chemicals or materials may also increase the risk of cancer. These substances include arsenic, asbestos, chloride, formaldehyde, certain alloys or pigments, and other chemicals. Family history of lung cancer may also heighten one’s chance of developing NSCLC.

The early stages of this cancer cause symptoms such as chest pain, coughing to the point of coughing up blood, fatigue, a loss of appetite, shortness of breath, losing weight, and wheezing. Later stages see pain and tenderness in the bones, drooping eyelids, a hoarse or different voice, joint pain, nail problems, facial swelling, weakness, and trouble swallowing.

A diagnosis is obtained through a physical exam and evaluation of family and medical history. Tests are performed to confirm the diagnosis, as well as to assess the spread. These tests include bone scans, chest x-rays, MRIs, CT scans, complete blood counts, PET scans, sputum tests, thoracentesis, and biopsies. Further testing may be necessary to stage the cancer.

Surgery is typically the first step in treatment. The procedure may remove a lobe of the lung, a segment of the lung, or the entire organ. Other forms of treatment include chemotherapy, targeted therapy, laser therapy, photodynamic therapy, and radiation therapy.

About Atezolizumab

Atezolizumab is a monoclonal antibody. It binds to proteins on the cells of tumors, called PD-L1. Its supplemental biologics license application has been accepted by the FDA, and it has also been given priority review.

It is currently being studied for NSCLC in the IMpower110 clinical trial. Roche plans to indicate this treatment for multiple other cancers in the future.

The IMpower110 Study

This trial is open-label and randomized. It has recently completed its third phase, which evaluated the safety and effectiveness of atezolizumab in comparison to chemotherapy. Those who participated in this study were required to have advanced NSCLC without ALK or EGFR mutations.

Overall survival grew by 7.1 months in those treated with atezolizumab, and adverse events were only present 12.9% of the time, compared to 44.1% with chemotherapy. While overall survival was the primary endpoint, researchers also looked at progression-free survival, duration of response, and objective response rate. These results were observed within a study population of 572.

NSCLC composes about 85% of lung cancer cases, meaning that atezolizumab may be a viable treatment for the majority of those with lung cancer. Researchers hope that future studies provide positive results so this treatment is able to help people.

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